(63 days)
The purpose and function of the Mediana ARGUS VCM vital signs monitor is to monitor non-invasive blood pressure (systolic, diastolic, and mean arterial pressures), functional arterial oxygen saturation, pulse rate for adult, pediatric and neonate patients and temperature for adult and pediatric patients in all hospital areas and hospital-type facilities. It may be used during hospital transport and in mobile, land-based environments, such as ambulances, within the specification of the environmental characteristics.
- Note: Hospital use typically covers such areas as general care floors, operating rooms, special procedure areas, intensive and critical care areas, within the hospital plus hospital-type facilities. Hospital-type facilities include physician office based facilities, sleep labs, skilled nursing facilities, surgicenters, and sub-acutecenters.
- Note: Intra-hospital transport includes transport of a patient within the hospital or hospital-type facility.
The ARGUS VCM vital signs monitor is to monitor non-invasive blood pressure, pulse rate, non-invasive functional oxygen saturation of arterial hemoglobin (SpO2) for adult, pediatric and neonate patients and body temperature for adult and pediatric patients in general hospital and alternate care facilities by medically trained personnel. This monitor is available for sale only upon the order of a physician or licensed health care professional.
The Mediana ARGUS VCM vital signs monitor is a lightweight and compact device (180×278×130 mm and 2.7 kg) powered by AC mains (100-240VAC, 50-60Hz) and also powered by internal battery. The monitor provides patient data and monitoring status on 7segment and LED displays.
The provided text is a 510(k) Summary of Safety and Effectiveness for the Mediana ARGUS VCM series, Vital Signs Monitor. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study with specific acceptance criteria and performance metrics of the new device itself.
Therefore, much of the requested information cannot be extracted directly from this document. Here's what can be inferred and what is explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of acceptance criteria with numerical targets and the Mediana ARGUS VCM series' specific performance against these targets. Instead, it relies on demonstrating substantial equivalence to predicate devices by stating that its specifications and performance are equivalent to those predicate devices.
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Non-Invasive Blood Pressure (NIBP) measurement specifications and performance | Equivalent to Welch Allyn Protocol vital signs monitors, Model 53000 Series and Model Propaq LT 802 Series. | Stated as "equivalent to the Welch Allyn Protocol vital signs monitors, Model 53000 Series and Model Propaq LT 802 Series." |
| Pulse rate specifications and performance (derived from NIBP or SpO2) | Equivalent to Welch Allyn Protocol vital signs monitors, Model 53000 Series, and Nellcor Puritan Bennett Pulse Oximeter Model N-550. | Stated as "equivalent to the Welch Allyn Protocol vital signs monitors, Model 53000 Series, and the Nellcor Puritan Bennett Pulse Oximeter Model N-550." |
| Pulse Oximetry (SpO2) specifications and performance | Equivalent to Nellcor Puritan Bennett Pulse Oximeter Model N-550. | Stated as "equivalent to the Nellcor Puritan Bennett Pulse Oximeter Model N-550." |
| Temperature specifications and performance | Equivalent to Welch Allyn Protocol vital signs monitors, Model 53000 Series and the Vital Signs Monitor (VSM). | Stated as "equivalent to the Welch Allyn Protocol vital signs monitors, Model 53000 Series and the Vital Signs Monitor (VSM)." |
Explanation: The "acceptance criteria" here are implied to be the performance characteristics of the predicate devices. The "reported device performance" is a statement of equivalence rather than specific numerical results. The document explicitly states that the Mediana device uses the same NIBP module (Welch Allyn NIBP module POEM), the same SpO2 module (Nellcor Oximetry module MP506), and the same temperature module (Welch Allyn thermometry module SureTemp®) as its predicate devices, which is the primary basis for claiming equivalence in these specific areas.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document mentions "system V & V plan (#PA300-09000) and summary (#PA300-09013)" were used, but details on sample size for testing are not included in this summary.
- Data Provenance: Not specified. The context suggests that the testing would have been conducted by Mediana Co., Ltd. in Korea, but no details on the origin of any clinical data (e.g., country of origin, retrospective or prospective) are provided. The testing primarily appears to be technical verification and validation, rather than a clinical study with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document does not describe a study involving expert-established ground truth for the device's performance. The "ground truth" for demonstrating equivalence is based on the specifications and performance of the predicate and the use of the same core measurement modules.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication method is typically used in AI/diagnostic imaging studies for establishing ground truth, which is not the nature of the testing described here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/diagnostic imaging device. It is a vital signs monitor, and the studies mentioned are focused on demonstrating technical performance and equivalence, not comparing human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a way. The "performance testing" described ("system V & V plan (#PA300-09000) and summary (#PA300-09013)") would assess the device's functional performance in isolation, independent of human interaction beyond operating the device. However, this is not in the context of an "algorithm only" as typically understood in AI devices. It refers to the performance of the integrated vital signs monitor.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" implicitly used for the claim of substantial equivalence is the established and legally marketed performance of the predicate devices, particularly when the same core measurement modules are utilized. For technical verification and validation, the ground truth would be precise reference measurements from calibrated equipment (e.g., for blood pressure, SpO2, and temperature).
8. The sample size for the training set
Not applicable. This device is not an AI algorithm that requires a training set. Its design is based on established vital signs monitoring technologies, some of which are explicitly stated to be the same modules as in the predicate devices.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).